Damsbo N
Odense Universitet, Institut for Sygdomsforebyggelse og Helsetjenesteforskning (ISH).
Ugeskr Laeger. 1994 Oct 24;156(43):6384-8.
Fifty patients with mild asthma were randomized in a double-blind, parallel group design; 13 were protocol violators. Of the remaining 37, 20 patients were treated with budesonide, 17 with placebo. The Peak Expiratory Flow rate (PEF) was the main variable. In a diary, patients recorded PEF morning and evening, score of asthma symptoms and use of inhaled beta 2-agonist. Peak-flow and Goldberg's General Health Questionnaire were obtained at clinic visits. Parametric and non-parametric tests were used. All tests were two-tailed with a significance level of 0.05. The study proved that changes in the patients' PEF happened in the early phase of the treatment period. The increase in both morning and evening PEF and physical activity in the budesonide group were statistically significantly better than in the placebo group. There was no statistical difference between the two groups concerning the patients' general well-being as evaluated by Goldberg's General Health Questionnaire. No serious adverse events occurred. The conclusion is that patients with mild asthma had statistically significant effect on their morning and evening PEF and physical activity from treatment with a daily dose of 400 microgrammes budesonide given via Turbuhaler compared to treatment with placebo.
50例轻度哮喘患者按双盲平行组设计进行随机分组;13例违反方案。其余37例中,20例患者接受布地奈德治疗,17例接受安慰剂治疗。呼气峰值流速(PEF)是主要变量。患者在日记中记录早晚的PEF、哮喘症状评分及吸入β2受体激动剂的使用情况。在门诊就诊时获取峰值流速和戈德堡综合健康问卷结果。使用了参数检验和非参数检验。所有检验均为双侧检验,显著性水平为0.05。研究证明,患者的PEF变化发生在治疗期的早期。布地奈德组早晚PEF的增加及体力活动在统计学上显著优于安慰剂组。根据戈德堡综合健康问卷评估,两组患者的总体健康状况无统计学差异。未发生严重不良事件。结论是,与安慰剂治疗相比,轻度哮喘患者每日通过都保吸入400微克布地奈德治疗,其早晚PEF及体力活动有统计学显著效果。